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Randomized Controlled Trial
. 2010 Jul;31(14):1717-21.
doi: 10.1093/eurheartj/ehq113. Epub 2010 Apr 30.

Dronedarone in patients with congestive heart failure: insights from ATHENA

Stefan H Hohnloser  1 , Harry J G M Crijns, Martin van Eickels, Christophe Gaudin, Richard L Page, Christian Torp-Pedersen, Stuart J Connolly; ATHENA Investigators
Affiliations
Randomized Controlled Trial

Dronedarone in patients with congestive heart failure: insights from ATHENA

Stefan H Hohnloser et al. Eur Heart J. 2010 Jul.

Abstract

Aims: Dronedarone is a new multichannel blocking antiarrhythmic drug for treatment of atrial fibrillation (AF). In patients with recently decompensated congestive heart failure (CHF) and depressed LV function, the drug was associated with excess mortality compared with a placebo group. The present study aimed to analyse in detail the effects of dronedarone on mortality and morbidity in AF patients CHF.

Methods and results: We performed a post hoc analysis of ATHENA, a large placebo-controlled outcome trial in 4628 patients with paroxysmal or persistent AF, to evaluate the relationship between clinical outcomes and dronedarone therapy in patients with stable CHF. The primary outcome was time to first cardiovascular (CV) hospitalization or death. There were 209 patients with NYHA class II/III CHF and a left ventricular ejection fraction < or =0.40 at baseline (114 placebo, 95 dronedarone patients). A primary outcome event occurred in 59/114 placebo patients compared with 42/95 dronedarone patients [hazard ratio (HR) 0.78, 95% CI = 0.52-1.16]. Twenty of 114 placebo patients and 12/95 dronedarone patients died during the study (HR 0.71, 95% CI = 0.34-1.44). Fifty-four placebo and 42 dronedarone patients were hospitalized for an intermittent episode of NYHA class IV CHF (HR = 0.78, 95% CI = 0.52-1.17).

Conclusion: In this post-hoc analysis of ATHENA patients with AF and stable CHF, dronedarone did not increase mortality and showed a reduction of CV hospitalization or death similar to the overall population. However, in the light of the ANtiarrhythmic trial with DROnedarone in Moderate to severe CHF Evaluating morbidity DecreAse study, dronedarone should be contraindicated in patients with NYHA class IV or unstable NYHA classes II and III CHF.

Trial registration: ClinicalTrials.gov NCT00174785.

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Figures

Figure 1
Figure 1
Kaplan–Meier cumulative incidence curves of time to first cardiovascular hospitalization or death in patients with NYHA II/III congestive heart failure and left ventricular ejection fraction ≤0.40 at baseline assigned to dronedarone or placebo.
Figure 2
Figure 2
Forrest plot for first cardiovascular hospitalization or death in the overall ATHENA population and patients with or without NYHA II/III congestive heart failure and left ventricular ejection fraction ≤0.40 at baseline.
Figure 3
Figure 3
Changes in serum creatinine concentration relative to baseline values during the course of the study in patients with NYHA II/III congestive heart failure and left ventricular ejection fraction ≤0.40 at baseline assigned to dronedarone or placebo.
See this image and copyright information in PMC

References

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